THD Revolution THD Slide One USA
by Thd SpA
THD Revolution THD Slide One USA (800070) is a Class II device made by Thd SpA, cleared under FDA 510(k) K141657 on 24 Feb 2015 (1 earlier submission), registered in EUDAMED and listed in FDA GUDID since 30 Sep 2016 (UDI-DI 08033737710739), active as of 23 Oct 2026.
Active
CE MDR 510(k)
Valid until
No date given
FDA recalls
None found
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing GUDID | Number08033737710739 | Date30 Sep 2016 | StatusListed |
| United States | FDA 510(k) 510(k) | NumberK141657 | Date24 Feb 2015 | StatusActive |
| United States | FDA 510(k)SESE GUDID | NumberK090009 | Date28 Jan 2009 | StatusActive |
| European Union | CE/MDR EUDAMED | Number— | Date— | StatusActive |
Official records
- EUDAMED public site
- AccessGUDID record 08033737710739
- FDA 510(k) database K141657
- FDA 510(k) database K090009
Across registries
- FDA 510(k) K141657 decided 24 Feb 2015 Active
- EUDAMED Active
- FDA GUDID UDI-DI 08033737710739 listed 30 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K090009
- Cleared FDA 510(k) K141657
- Listed FDA GUDID 08033737710739
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- United States
- European Union
Specification
- Trade name
- THD Revolution
- Generic name
- Invasive vascular ultrasound system probe
- Model / Ref / Catalog
- THD Slide One USA, 800070
- Primary DI / UDI-DI
- 08033737710739
- 510(k) Number
- FDA product code
- JAF
- GMDN term
- Invasive vascular ultrasound system probe
- Device class
- Class II
- Regulation number
- 892.1540
- GUDID distribution status
- In Commercial Distribution
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